MAUDE Adverse Event Report: ICON CLINICAL RESEARCH POLYSITE; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 2016PI

Device Problems Detachment Of Device Component (1104); Misassembly by Users (3133)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/25/2018

Event Type  malfunction  

Event Description

Provider did not connect the mediport pieces together correctly prior to implanting the device.The device then came apart within the patient and had to be removed.This was a user error issue, not technically a device failure.

• Brand Name: POLYSITE
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ICON CLINICAL RESEARCH; 2100 pennbrook pkwy; north wales PA 19454
• MDR Report Key: 7534306
• MDR Text Key: 108924051
• Report Number: 7534306
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 2016PI
• Device Lot Number: 17100189
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR